Sunday, March 26, 2017

From time to time, friends, patients and relatives ask my
advice on participating in a medical experiment. My response has been no. More accurately, once I explain to them the realities
of research, they don’t need to be persuaded.
They back away.

Here’s the key point.
When an individual volunteers to join a research project, the medical
study is not designed to benefit the individual patient. This point is sorely misunderstood by
patients and their families who understandably will pursue any opportunity to
achieve some measure of healing for an ailing individual. I get this.
In addition, I believe that these research proposals are often slanted
in a way to suggest that there may direct benefit that the patient will
receive. I am not accusing the medical
establishment of uttering outright falsehoods to prospective study patients, but
there are two powerful forces that may incentivize investigators to recruit
patients with undue influence.

The Medical Research Industrial Complex is a voracious beast
that needs a steady diet of new recruits.
In other words, the beast must be fed.

Investigators have bias favoring their research and
truly believe that the new drug has a real chance of helping study
patients.

The truth is this. In
general, research projects are designed to generate new knowledge that
will be used to help patients down the road, not those in the study. Of course, I cannot state with absolute
certainty that a study patient won’t realize a favorable result, but this
serendipitous outcome is not the study’s planned yield. It should be viewed as a happy accident. This is why the study is properly called a research experiement.

Napoleon Has Stomach Pain.

Should He Join a Study?

Beware of the packaging.
If your mom or dad has Alzheimer’s disease, of course, you would be
susceptible to the following hypothetical pitch.

Is someone you love struggling against Alzheimer’s disease? Our Neurological Institute is fighting hard against this disease and is now testing a
new drug to help conserve memory. Call for
confidential information.

Recently, in France, 90 volunteers took a study medicine
testing the safety of a psychiatric medication.
One volunteer is now dead and others have suffered irreversible
brain damage. We don’t know the underlying facts
yet. While a horrible outcome is not
tantamount to guilt, this is a terribly troubling event that must be sorted out.

We will find out soon enough if the French study subjects were given all the information they were entitled to, and if the investigators and others behaved properly. The investigation that must be full and fair. A conclusion of c’est la vie won’t be enough.

If you want to join a medical study to serve humanity – and not
yourself – then you are free to make an informed choice. Be mindful of the risks including those that are not known.

Sunday, March 19, 2017

Promoting medical marijuana use is hot – smokin’ hot. States are racing to legalize this product,
both for recreational and medical use.
In my view, there’s a stronger case to be made for the former than the
latter.

Presently, marijuana is a Schedule I drug, along with
heroin, LSD and Ecstasy. The Food and
Drug Administration (FDA) defines this category as drugs with no acceptable
medical use and a high potential risk of addiction. Schedule I contains drugs that the FDA deems
to be the least useful and most dangerous.
Schedule V includes cough medicine containing codeine.

On its face, it is absurd that marijuana and heroin are
Schedule I soulmates. I expect that the
FDA will demote marijuana to a more benign category where it belongs. It will certainly have to if marijuana is
going to be approved as a medicine.

There is no question that some advocates favoring
medicalization of marijuana were using this as a more palatable route to
legitimize recreational use. The
strategy was to move incrementally with the hope that over time the ball would
cross the goal line. We have seen this
same approach with so many other reforms, legal decisions and societal
acceptances, many of which we take for granted.
Consider gay marriage and women’s role in the military as two examples
of goals that required a long journey to reach.

Marijuana has had no personal or professional role in my
life. I do not object to responsible
recreational use and would support such a measure. To criminalize marijuana use while cigarettes,
chewing tobacco and alcohol are entirely legal seems inconsistent and
hypocritical. Is smoking marijuana more
dangerous than riding a motorcycle?

Paradoxically, I have hesitancy at this point to endorse
medical marijuana use based on the fragmentary data that supports its
efficacy. If you ‘Google’ this subject,
and you believe what you read, you will conclude that marijuana is the panacea
we’ve been waiting for. It helps
nausea, neuropathic (nerve) pain, glaucoma, muscle spasms, Crohn’s disease,
multiple sclerosis, epilepsy, Hepatitis C, migraines, arthritis, Alzheimer’s
disease, cancer and numerous other ailments.
Do we accept so readily that one agent can effectively attack such a
broad range of unrelated illnesses? It
sounds more like snake oil than science.

The medical profession and our patients should demand that
all our medicines be rigorously tested for safety and efficacy. I realize that there is huge public
acceptance that marijuana is real medicine.
Not so fast. Let the FDA evaluate
marijuana as it does for all medications and treatments. I do not think we should relax our
professional standards just because the public is willing to inhale without
evidence and entrepreneurs want to cash in.

If you had a chronic disease, would you expect your doctor
to offer you a medicine with definite risks but no proven benefit? Why would you accept it and why would he
prescribe it?

Sunday, March 12, 2017

Why are the costs of prescription drugs so high? While I have prescribed thousands of them, I
can’t offer an intelligent answer to this inquiry. Of course, all the players in this game – the
pharmaceutical companies, Pharmacy Benefit Managers, insurance companies,
consumer activists and the government- offer their respective bromides, where
does the truth lie?

While I don’t fully understand it, and I don’t know how to
fix it, we all know that the system is broken.
More than ever before in my career, I am seeing patients who cannot
afford the medicines I prescribe for them.
In the last few weeks of this writing, 3 patients with colitis, a
condition where the large bowel is inflamed, called me to complain about the
cost of their new medicine. The annual
cost was in the $2,500 - $3,000 range, which is way out of range for normal
folks. While I was only focused on the
colitis drug, many of these patients face prohibitive costs over multiple
medicines. All of these patients had
medical insurance, thought it didn’t feel like it to them.

Medicine or Retirement?

Should sick patients be given the added burden of price gouging?

I'm not an attack dog against PhRMA. I've expressed sympathy on this blog and elsewhere that it costs pharmaceutical companies a fortune to design, test and market new medicine. R & D is not cheap. If we want this industry to take risks developing tomorrow's drugs, then they deserve a profit high enough to justify the investment. Nevertheless, from the prescribers and the consumers points of view, the system is out of balance and needs to be recalibrated.

I reviewed my colitis patients' formularies, which is the list of medicines
that patients' insurance companies cover.
If a drug is labeled as a ‘Tier 1’ drug, then the cost to the patient is
the lowest. The higher the Tier #, the
more the patient will pay. This is how
the insurance company ‘guides’ physicians to prescribe cheap drugs. Of course, the insurance company will never
say that the patient can’t receive an expensive drug. That’s a decision, they claim with a straight
face, that’s between a patient and the doctor.
Give me a break. Ordinary folks,
especially retired people on fixed incomes, are confined to lower Tier
medicines.

I have no issue with the Tier system as long as there is at
least one Tier 1 drug that can do the job.
If there are half a dozen heartburn medicines that are equally
effective, I understand if an insurance company makes one of them Tier 1, their
preferred choice. This happens when the
insurance company gets a special discount on this particular medicine.

With regard to my 3 colitis patients, the only Tier 1 drug
was one that came on the scene decades before I was born. The standard colitis medicines that every
gastroenterologist would have prescribed were all upper Tier. My patients had no choice but to accept an
inferior drug.

If any reader can explain why our drug prices are the
highest in the world, can you also explain why insurance companies are not
practicing medicine?

Sunday, March 5, 2017

For me, the test of fairness, which many of us fail, is if we
would have the same view of events if the situation were reversed.

An employee approaches his boss requesting a raise,
pointing out that he has not had a raise in 2 years, while other colleagues
have received pay increases. The boss
responds that while his performance was highly satisfactory, the colleagues who
did receive pay raises demonstrated sterling reviews. The employee believes this decision is
unfair, and suggests there may have been some favoritism at play. The
fairness test here is what would the employee do if he were the manager.

A nursing supervisor is told that two nurses on a hospital
ward are unable to report to their shift.
Each nurse has to carry a heavier patient load for that shift. These nurses believe that they are entitled
to additional compensation as their already heavy work load has been
increased. This request is denied by the
hospital’s administration. I wonder if
the hospital administrators would agree with their edict if they were the
overworked nurses on that shift. Would they still agree that no additional pay for additional work is downright fair? Can't you just hear them saying that if they were these nurses that they would welcome
the opportunity to be saddled with extra work and would refuse any offer for
additional comp. (Readers are invited to
laugh at this point.)

Events always look a little different when we swap
places.

The Attorney General of the United States, Jeff Sessions, is
the newest star performer on CNN and other networks this week. He gave misleading responses during his
confirmation hearings when asked if he had any contact with Russian officials
during the campaign. In addition, he did
not correct his misstatements afterwards until his 2 meetings with the Russian
ambassador were disclosed. He has been
accused of lying and deceiving congress, an allegation that he denies. He claims that he misunderstood the question
and had no intent to mislead anyone.

Public Enemy #1?

Personally, I am not satisfied with his inaccurate testimony
and subsequent silence Did he
lie? I’m not sure. If so, it would seem to be a poor choice
since telling the truth of the two meetings could have been justified and
explained.

Many Democrats are screaming for his resignation and for a
special counsel to be brought in to assess the situation independently. I suggest that the reasons behind these two
Democrat requests have nothing to do with Sessions’ behavior, but deserve a
larger context, which I’m sure my readers will acknowledge.

We all know that when there is an independent counsel that
the investigation always morphs into a mega-mission creep that extends far
beyond the initial target. That’s why
political partisans always zealously request this measure when the other party
is under attack, but push back hard when they are in the crosshairs.

Now for the fairness test.
Remember when the Democrats were screaming and whining when independent
counsel Ken Starr was on the attack? His
mission started with Whitewater but was incrementally expanded and extended to the Monica Lewinsky
affair. I think the Democrats had a
valid point that his investigation became untethered. However, is an independent counsel only fair
when your opponents are being targeted?

As for Jeff Sessions resigning, I think this is transparent
partisanship. How would the Dems react
if the situation were reversed? The
experiment has already been done.
Remember when Loretta Lynch, the Attorney General had a near hour long
meeting with Bill Clinton on the tarmac while Mrs. Clinton was the target of an
FBI investigation? Quite a long time to
be discussing golf and grandchildren.

How many Democrats called upon her to resign or face a special
prosecutor? Have they passed the fairness test?

Of course, many partisan Democrats will point out the the Lynch affair is 'completely different' from the Sessions matter. How stupid do they think we are?

I'm taking aim at the Democrats here, but I fully acknowledge that the GOP also fails the fairness test regularly.

Search This Blog

Subscribe To Whistleblower!

MD Whistleblower

About Me

I am a full time practicing physician and writer. I write about the joys and challenges of medical practice including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When I'm not writing, I'm performing colonoscopies.